Battelle Gets FDA Emergency Use Authorization for N95 Respirator Decontamination System
On Saturday, FDA issued an Emergency Use Authorization for the Battelle’s CCDS Critical Care Decontamination System for use in decontaminating compatible N95 respirators used by healthcare personnel. Per the agency’s letter to Battelle, one N95 mask can be decontaminated up to 20 times.
“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Battelle Decontamination System may be effective at preventing exposure to pathogenic airborne particulates when there are insufficient supplies of FFRs during the COVID-19 pandemic by decontaminating, for a maximum of 20 decontamination cycles per respirator, compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms, and that the known and potential benefits of the Battelle Decontamination System, when used to decontaminate compatible N95 respirators for reuse by HCP to prevent exposure to pathogenic airborne particulates during FFR shortages during the COVID-19 pandemic, outweigh the known and potential risks…” – Denise M. Hinton, chief scientist, FDA
Battelle’s self-contained system uses vapor phase hydrogen peroxide to decontaminate the masks. The CCDS system is based on effective and proven published research that Battelle conducted for the FDA in 2015 and has been shown to be effective against viral and bacterial agents. FDA has stated that all healthcare facilities that want to use the system must receive the “Instructions for Healthcare Personnel” that informs them of how to prepare their own N95 respirators for decontamination.
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